Branemark System Interlocking Abutment/Gold Cylind

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K925776 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Branemark System 17 Angulated Abutment

  Class II

  FDA 510(k) K944962 Active Cleared 27 Feb 1995

• Branemark System

  Class II

  FDA 510(k) K934825 Active Cleared 8 Aug 1994

• Branemark System Estheticone Abutment Complete

  Class II

  FDA 510(k) K925777 Active Cleared 14 Apr 1993

• Branemark System-3.0mm Fixture

  Class II

  FDA 510(k) K911960 Active Cleared 19 Dec 1991

• Miruscone Abutment System

  Class II

  FDA 510(k) K961728 Active Cleared 10 Jul 1996

• Branemark System Single Tooth Abutments, Inst&Comp.

  Class II

  FDA 510(k) K925767 Active Cleared 20 Oct 1993

See all devices from Nobelpharma USA, Inc. →

• What types of dental restorations can this gold cylinder abutment support, and how does it attach to the implant fixture?

  The Branemark System Interlocking Abutment Gold Cylinder is designed for single-unit implant restorations and supports both cement-retained and screw-retained crowns or prostheses. It provides a precision-fitted interface between the implant fixture and the prosthetic restoration, ensuring mechanical stability and secure attachment for long-term use.

• Is this abutment meant for single-use or can it be reused in multiple procedures?

  This gold cylinder is supplied as a reusable component, intended for use in sterile surgical settings by dental professionals. To maintain its integrity and sterility, it must be handled and stored according to strict sterile protocols before each clinical use.

• What compatibility considerations should clinicians keep in mind when using this abutment?

  The Branemark System Interlocking Abutment Gold Cylinder is specifically designed to work with the Branemark System MK III Groovy and other compatible implant analogs. This ensures a proper fit and function in implant-supported restorations, so clinicians should verify compatibility with their chosen implant system before use.

• How should this abutment be stored to ensure it remains suitable for clinical use?

  Since this component is reusable, it must be stored and handled under sterile conditions to preserve its integrity. Proper storage protocols are critical to prevent contamination and ensure the abutment remains suitable for use in surgical settings when needed.

• What regulatory pathway does this device follow, and what does that mean for its use in dental practices?

  The Branemark System Interlocking Abutment Gold Cylinder received FDA 510(k) clearance under product code DZE, indicating it is deemed substantially equivalent to a legally marketed device for dental applications. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in osseointegrated implant restorations.